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Braun Omnitest Plus

Device Name:Omnitest Plus
Manufacturer:B. Braun Melsungen AG, Carl-Braun-Straße, 134212 Melsungen, GERMANY.
Measuring functions:Blood glucose
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Finger
Measurement Occurrence:Single measurements only
Availability:Available Currently
Description: The Braun Omnitest Plus is a non-clinically-validated blood glucose meter. Measurements are taken from the finger and it is intended for self-measurement and home use.
Assessment:

The technology used in the Braun Omnitest Plus, to measure blood glucose, has failed in a clinical validation study, in a specific population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Accuracy AssessmentRecommendationBasis
MedavalNot recommendedThis device failed clinical validation.

Validation Publications

Pfützner A, Schipper C, Ramljak S, Flacke F, Sieber J, Forst T, Musholt PB. Evaluation of the effects of insufficient blood volume samples on the performance of blood glucose self-test meters. J Diabetes Sci Technol. 2013 Nov 1;7(6):1522-9. doi: 10.1177/193229681300700612. PMID: 24351178. Available from: PMC3876330.

15197:2003 - Fail Using insufficient blood samples (n=31)